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Experimentation, Medical

EXPERIMENTATION, MEDICAL

Principles

Medical experimentation raises a moral question as far as it submits human subjects either to medical treatments not as yet scientifically established or to procedures employed only for the purpose of discovering some truth or of verifying some hypothesis. If the experiment entails any significant risk or hardship for the subject, the matter becomes theologically one of moral rights and duties relative to proper respect for human life and health.

Experimentation admits of two possible objectives: benefit to the individual who submits to experimental measures, or the advance of medical science and consequent benefit to the common good. Accordingly as one or the other purpose is sought exclusively, or at least is paramount in the intention of the participants, two distinct moral problems present themselves.

For the subject's benefit. When the good of the individual patient is the physician's exclusive or predominant concern, the canons of good medicine will dictate the course of a treatment that it is the doctor's duty to provide. Thus, if a sure remedy is available, it should ordinarily be employed in preference to treatment of doubtful efficacy. Or if the only choice of remedy lies among several that are at best doubtful, the most promising should generally be used. The patient is entitled in justice to the surest means reasonably available for achieving the object of his medical contract, viz, the cure or control of his malady.

But it is also true that if a proven remedy would entail exceptional expense, pain, or other hardship, the patient may be justified in choosing instead a treatment whose effectiveness is as yet incompletely established but that circumvents the disadvantage presumably inherent in his using the proven procedure. The patient, in other words, may legitimately run the risk, even though it be considerable, of a less certain remedy, provided there is a proportionately serious reason for so doing. A fortiori, if there is little or no risk involved in accepting a remedy of dubious efficacy, it is undeniably the patient's right to make that choice for any reasonable motive.

But a decision of this kind is the patient's prerogative and not the doctor's. Hence the doctor must prefer the certain to the uncertain remedy, or the more probable to the less probable, unless the patient's rightful choice to the contrary is explicitly expressed either by him or by his legitimate representative, or unless this consent can be reasonably presumed.

For the benefit of others. In order to discern the limitations to be placed on human experimentation undertaken for the benefit of others, one must appreciate two moral truths. The first is simply a denial of that extremist philosophy that we have come to identify as totalitarianism and that would subject the individual completely to the community or state by subordinating all individual rights to the prior claims of the common good. Such a philosophy, in its most blatant form, found expression in the experimental excesses encouraged and practiced under Nazism and later repudiated by the free world in the formulation at Nuremberg of a ten-point statement of limitations to be placed on medical experiments performed on human subjects. Put positively, this principle asserts that, with regard to his life and bodily integrity, each individual possesses a God-given right of immunity from unprovoked attack by any other person. No individual, therefore, can legitimately be considered an expendable member of society to be exploited for the common good. For this reason it follows, in the words of Pius XII, that "the doctor can take no measure or try no course of action without the consent of the patient." Consequently, laudable as may be the desire to contribute to the advancement of medical science, doctors are nonetheless restricted in their human experimentation by this inalienable right of any individual to forbid such use of his organic entity. As the first rule of the Nuremberg Tribunal expresses it, "The voluntary consent of the human subject is absolutely essential."

The second pertinent principle denies what might be called extreme individualism on our part and imposes certain basic limitations on each one's right to dispose of his own life and bodily members. Because of his creaturehood, man must admit himself to be essentially dependent upon his Creator. In context, this dependence means that man is not the absolute master of his body and life. He is not proprietor of himself, but rather a custodian entrusted with the care of "property" that belongs strictly to God. He may, therefore, administer this trust only in compliance with the divine will as manifested to him in various ways.

The first corollary from this principle is the prohibition of the natural law against suicide. To intend directly the termination of one's own life is to usurp a right that belongs exclusively to God. There are circumstances in which we are justified in risking our lives if necessary for the achievement of some momentous good; but in such cases, death, if it should occur, is the unintended byproduct of an act legitimately performed for another reason and is not imputable as a moral evil. Even for the laudable purpose of advancing medical science, no one would be justified in making his own death the intended means to that end.

A second consequence of the same principle relates to bodily damage short of death that for one or another reason one might inflict upon himself or allow another to inflict. We are responsible to God not only for life itself but also for our physical integrity, and only within certain limits may we legitimately mutilate our bodies or suppress their natural functions. According to the principle of totality, for example, one is allowed to sacrifice a bodily member should this be necessary or useful for the good of his own person as a whole. But this principle has no application in a context of investigative procedures undertaken exclusively for the benefit of others. Does any other principle ratify the risking of one's bodily integrity for altruistic motives?

Certainly there are circumstances wherein the principle of charity i.e., love for fellow mandoes legitimatize a certain degree of bodily self-sacrifice on behalf of others. Theologians unanimously agree, for example, that blood transfusions and heterologous skin grafts are morally permissible. On the strength of the same principle, many moralists of highest repute vigorously defend some forms of organic transplantation inter vivos, always with certain qualifications that sound medicine would also stipulate. Finally, although one may not intend his own death as a means of saving another's life, it is sometimes permissible deliberately to perform a heroic act that will have two immediate effects, viz, preservation of another's life and the unintended but inevitable loss of one's own. In none of these instances does any bodily benefit accrue to the donor subject. In fact, the contrary is true, especially where the sacrifice of an organ or risk to life is concerned.

Conclusion. It is clear that the immanent teleology of our corporal being does admit of a certain ordination to the benefit of others. In terms of experimental medicine, it would also seem that charity would countenance a limited degree of risk to life or bodily integrity in circumstances that make human experimentation genuinely necessary. But where does one draw the line beyond which one may not licitly go in this regard? No general answer, applicable to all cases indiscriminately, is possible. Each individual case must be judged on its own merits. An attempt must be made to judge whether there is sufficient reason to justify the necessary risk or harm entailed in the particular procedure contemplated. However, the following generic norms can be suggested as morally safe in practice: (1) When bodily damage or risk to life is foreseen as insignificant, there is no valid reason to forbid a willing subject to consent to the procedure in question. (2) No one may legitimately consent to a procedure that entails certain death as a necessary means of achieving the experiment's purpose. (Although it has been suggested by some that a criminal already justly condemned to death might licitly choose this form of execution, such a possibility would represent the sole exception to an otherwise universal rule.)

In the vast intermediate area where hazard to life or health may range from notable to very serious, the maximum limit of permissible risk cannot be sharply defined. But it would seem safe to say that, for a proportionately grave reason, a subject may for the benefit of others authorize and submit to any experimental procedure that will not seriously and permanently impair his functional integrity or cause serious risk of life. Implicit in this concession is the supposition that the procedure has been adequately tested short of human experimentation, that it promises reasonable hope of achieving a good proportionate to the risk, and that all reasonable care is taken to avoid even unintended harm to any who submit to the experiment.

Bibliography: pius xii, "Ce premier Congrès," (Address, Sept. 13, 1952) Acta Apostolicae Sedis 44 (1952) 779789; English tr. Catholic Mind 51 (May 1953) 305313; "Nous sommes heureux," (Address, Sept. 30, 1954) Acta Apostolicae Sedis 46 (1954) 587598; English tr. Catholic Mind 53 (April 1955) 242252. g. a. kelly, Medico-Moral Problems (St. Louis, Mo.1958) 261269. c. j. mcfadden, Medical Ethics (5th ed. Philadelphia, Pa. 1961) 249255. t. j. o'donnell, Morals in Medicine (2d ed. rev. and enl. Westminster, Md. 1959) 113120. j. paquin, Morale et médecine (3d ed. rev. Montreal 1960) 365371. j. j. lynch, "Human Experimentation in Medicine: Moral Aspects," Linacre Quarterly 27 (1960) 6267.

[j. j. lynch]

Recent Developments

Medical and public concern. Medical research and experimentation have provided the physician with considerably improved methods for dealing with human disease and dysfunction. Among these are antimicrobial agents for a variety of infectious diseases; organ transplantation for dealing with total kidney failure and selected heart conditions, as well as other organs such as the liver; better surgical techniques for repair of injuries to tissue and bone; chemotherapy and radiation therapy for cancer control; sophisticated diagnostic techniques such as computerized tomography (CAT); magnetic resonance imaging (MRI), ultrasonography, and numerous other laboratory tests which provide to the physician with more precise information about the condition of his patient; and a host of drugs to deal more effectively with hypertension, anxiety, pain, hormonal deficiencies, allergies, and many other human physical and mental dysfunctions. In addition, the recently completed Human Genome Project promises a bright future for the diagnosis and treatment of diseases at the genetic level.

As the benefits of medical research became more evident in everyday life, increased private and governmental funding has provided the means for still more research. Thus, national support (federal, state, industrial, and private nonprofit) for health research and disease in 1961 was $1.1 billion, while for 1976 it was about $5.1 billion, representing approximately 3.6% of a total health cost of $141.1 billion (National Institutes of Health 1977-Basic Data). The proposed 2002 budget for NIH alone is $23.1 billion (CNN.com).

Parallel with the increase in medical research has been an augmentation in the medical profession's concern about the ethical aspects of human experimentation. One measure of this increased interest is the notable increase in the number of publications in the medical literature which deal with the ethical dimensions of human experimentation. Public and professional interest has also been aroused with the revelation of several apparently flagrant examples of the violation of basic human rights associated with medical research. Such occurrences, it must be stressed, are rare. Recently considerable public interest has developed around the possibility of human cloning (after the announcement in February of 1997 of a cloned sheep, Dolly, with the consequent surfacing of many ethical questions. Similarly, the issue of the use of human stem cells for research and therapy has resulted in intense ethical discussions.

Governmental action. In 1974 Congress passed and the President signed into law, the National Research Act, establishing the National Commission for the Protection of Human Subjects of Biomedical and the Behavioral Research (Title II of Public Law 93348). The eleven-member commission assumed the task of (1) identifying the basic ethical principles which should undergird research involving human subjects; (2) developing appropriate guidelines; (3) making recommendations for administrative action to the Secretary of the Department of Health, Education, and Welfare (HEW). Over the subsequent years there have been structural changes in the Federal agencies so that the current relevant agency is the Office for Protection from Research Risks located in the Department of Health and Human Services (DHHS). The relevant Federal Regulations may be found in the Code of Federal Regulations, Title 45, Part 46, Protection of Human Subjects.

The early basic regulation governing the protection of human subjects in biomedical and behavioral research were published in the Federal Register on May 30, 1974. These regulations required, among other items, that (1) the risks be outweighed by the sum of benefits to the subject and the importance of the knowledge to be gained;(2) the rights and welfare of the subject be adequately protected; (3) legally effective, informed and free consent be obtained; (4) the research be reviewed at timely intervals. Each research site is to set up an Institutional Review Board (IRB) to review every research protocal involving human subjects. Without the IRBs approval that research may not proceed. Other regulations governing research when the subjects are fetuses, pregnant women, or the products of in vitro fertilization were issued on Aug. 8, 1975. These were modified and augmented by regulations published on Jan. 11, 1978. Proposed policies governing the use of psychosurgery in practice and research were issued on May 23, 1977, while publication of and invitation of public comment on the report and recommendations of the National Commission regarding research involving children appeared in the Federal Register on Jan. 13, 1978. All these regulations have been periodically updated. Part of a refinement and updating process initially included, and continues to include, consultation with the scientific community and interested public groups or individuals. The Federal Register remains a reliable information source of changes in Federal Regulations regarding the protection of human subjects in medical research.

Church teaching. Vatican Council II and Popes John XXIII and Paul VI in the area of medical research have primarily applied and reinforced what Pope Pius XII had already said at some length. In his address to the Pontifical Academy of Sciences on April 27, 1968, Pope Paul VI stated: "The Holy See intends to show that the Catholic Church respects scientific research, recognizes its freedom within its own domain, and looks forward eagerly to its present and future conquests" (The Pope Speaks 13 [1968] 108). In an earlier address to pediatric cardiologists, the pope stated the supreme rule for medical practice and research: "that man is 'the subject, the basis and the end' of life in society " (May 12, 1967; The Pope Speaks 12 [1967] 365). The pope's abiding concern is shown when he addressed the European Association of Hospital Doctors on April 28, 1973 and noted the need to "reconcile legitimate and necessary research with the personal rights of the patient, who can never be sacrificed as if the matter involved merely a part of humanity ordained to the good of the whole" (Pope Speaks 18 [1973] 6971). Finally, Pope Paul reiterated his central theme: "In this field of medical ethics, we would like once more to stress its foundation: unconditional respect for life, from its beginning" (Paul VI to the doctors of Flanders, April 23, 1977, Osservatore Rom May 5, 1977, 9). In his turn, Pope john paul ii made a number of notable contributions to the field of medical ethics. Among these are the following: The Splendor of Truth (veritatis splendor) 1993; The Gospel of Life (evangelium vitae) 1995; and several documents issued by the Congregation for the Doctrine of the Faith, and aproved by John Paul II, Declaration on Euthanasia (1980) and Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation (Donum Vitae ) (1987).

From these quotations and other papal statements it is evident that relative to medical research the magisterium asserts three main points: (1) Medical research is necessary and good but must be for the true welfare of human beings. (2) Human life must be respected by the individual and others at all stages of its existence; therefore, research risks are to be limited by the requirements of justice and charity. (3) Human persons are individually of inestimable value and may not under any conditions be used as mere means; consequently, informed and free consent is an absolute condition for human experimentation.

Informed consent. In practice, perhaps the area of greatest difficulty is the process of obtaining truly informed and freely given consent from the potential research subject. Government regulations provide a framework and a mechanism to assure some degree of compliance with the regulations. Nonetheless, ultimately the protection of the subject's basic human rights devolves on those doing the research. The assessment of the risk/benefit ratio depends much on the experimenter's own understanding of the research about to be undertaken. Obtaining appropriate informed consent from the potential research subjects rests in large measure on the researcher's having an attitude of profound respect towards human beings and on his ability to express the expected benefits and reasonably anticipated hazards in a manner that adequately informs and freely elicits the appropriate consent. Special groups such as the poor, the sick, employees, medical and graduate students are considered to be "consent prone" and thus require particular care to assure the absence of coercion. Other groups such as fetuses, the mentally retarded, children, and prisoners are especially vulnerable and thus are generally inappropriate for human experimentation, unless there is serious need and additional safeguards for the good and safety of the individual research subject are rigorously observed and enforced.

Bibliography: b. m ashley and k. d. o'rourke, Health Care Ethics, A Theological Analysis, 4th ed., t. l. beauchamp and l. walters, Contemporary Issues in Bioethics (Belmont, Calif.1978). r. l. bogomolny, Human Experimentation (Dallas, Tx.1976). p. cataldo and a. s. moraczewski, Catholic Health Care Ethics: A Manual for Ethics Committees (Boston, Mass. 2001). c. fried, Medical Experimentation: Personal Integrity and Social Policy (New York 1974). b. h. gray, Human Subjects in Medical Experimentation (New York 1975). n. hershey and r. d. miller, Human Experimentation and the Law (Germantown, Md. 1976). j katz, Experimentation with Human Beings (New York 1972). w.e. may, Human Existence, Medicine and Ethics (Chicago, Ill.1977). National Academy of Sciences, Experiments and Research with Humans: Values in Conflict (Washington, D.C. 1975). t. j. o'donnel, Medicine and Christian Morality (New York 1976). p. ramsey, The Patient As Person (New Haven, Conn. and London 1970). s. j. reiser, a. j. dyck, and w. j. curran, Ethics in Medicine: Historical Perspectives and Contemporary Concerns (Cambridge, Mass. 1977). j. j. shinners, The Morality of Medical Experimentation on Living Human Subjects in the Light of Recent Papal Pronouncements (Washington, D.C. 1958). m. b. visscher, Ethical Constraints and Imperatives in Medical Research (Springfield, Ill. 1975).

[a. s. moraczewski]

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